MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® LI-ION BATTERY; LI-ION BATTERY, RECHARGEABLE

Model Number	MODEL 100
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the autopulse platform (sn (b)(4)) does not power on with four fully charged autopulse li-ion batteries (sn (b)(4)).The issue was observed intermittently.It is unknown where the problem occurred.However, patient use information was requested but no additional information was provided.Please see the following related mfr reports: mfr 3010617000-2022-00578 for autopulse platform sn (b)(4).Mfr 3010617000-2022-00588 for autopulse li-ion battery sn (b)(4).Mfr 3010617000-2022-00589 for autopulse li-ion battery sn (b)(4).Mfr 3010617000-2022-00590 for autopulse li-ion battery sn (b)(4).
Additional Manufacturer Narrative
Zoll has not received the product for investigation.A follow-up report will be submitted when the product is returned and the investigation has been completed.
Additional Manufacturer Narrative
The customer reported a complaint that "the autopulse platform did not power on intermittently using the autopulse li-ion battery (sn (b)(6))" was not confirmed during the functional testing and archive review.Upon visual inspection, no physical damage was observed.The battery archive was downloaded and reviewed.A review of the battery archive did not show any errors or anomalies related to the reported complaint of not powering up the autopulse platform, however, on (b)(3) 2022, the battery recorded 3 in-out device events.No further events were recorded.The battery was last charged successfully on (b)(3) 2022, and was last used/inserted in the autopulse platform on (b)(3) 2022.During functional testing, the autopulse li-ion battery passed charging in a known good autopulse multi-chemistry battery charger (mcc), and the status leds of the battery showed four green lights after successful charging.The platform was tested with the battery (sn (b)(6)) and the battery performed as intended.

• Brand Name: AUTOPULSE® LI-ION BATTERY
• Common Device Name: LI-ION BATTERY, RECHARGEABLE
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 14484258
• Report Number: 3010617000-2022-00587
• Device Sequence Number: 20167449
• Product Code: MOQ
• UDI-Device Identifier: 00849111001861
• UDI-Public: 00849111001861
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: D163369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0752-16
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 05/24/2022
• Supplement Report FDA Received Date: 07/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown